Full Press Release Details
SAN FRANCISCO , Feb. 28, 2013 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR ) today reported its financial results for the fourth quarter and year ended December 31, 2012 .
Cash, cash equivalents, and investments at December 31, 2012 were $302.2 million as compared to $414.9 million at December 31, 2011 .
"As we enter 2013, Nektar is in an excellent position with five highly valuable late-stage programs across multiple therapeutic areas," said Howard W. Robin , President and Chief Executive Officer of Nektar. "With positive efficacy and safety results from the full Phase 3 KODIAC program for naloxegol, our partner AstraZeneca is preparing to submit registration filings in the U.S. and EU in the third quarter of this year. We are tremendously pleased that Bayer is scheduled to start the Phase 3 program next month for Amikacin Inhale in gram-negative pneumonia. Additionally, we expect to report key Phase 2 clinical data this summer for NKTR-181, our novel opioid analgesic, which represents a potential breakthrough for the treatment of chronic pain."
Revenue for the fourth quarter of 2012 was $21.1 million as compared to $15.8 million in the fourth quarter of 2011. Revenue for the year ended December 31, 2012 was $81.2 million as compared to $71.5 million in 2011. 2012 revenue included $10.8 million in non-cash revenues resulting from the $124 million sale of future royalties related to Cimzia® and Mircera®, which was completed in February 2012. This non-cash royalty revenue is offset by non-cash interest expense. For both the quarter and the year ended December 31, 2012 , product sales increased significantly. These increases were partially offset by decreases in royalty revenues.
Total operating costs and expenses in the fourth quarter of 2012 were $64.5 million as compared to $50.3 million in the fourth quarter of 2011. Total operating costs and expenses for the year ended December 31, 2012 were $222.4 million as compared to $195.4 million in 2011. The increases in 2012 as compared to 2011 are due primarily to increased clinical development expenses as well as higher cost of goods related to increased product sales.
Research and development expense in the fourth quarter of 2012 was $46.4 million as compared to $33.3 million for the fourth quarter of 2011. For the year ended December 31, 2012 , R&D expense was $148.7 million as compared to $126.8 million in 2011. R&D expense was higher in the fourth quarter and year ended December 31, 2012 as compared to the same periods in 2011 reflecting the costs of the etirinotecan pegol (NKTR-102) BEACON Phase 3 study, the production of devices for the Phase 3 study of Amikacin Inhale, the Phase 1 and Phase 2 studies for NKTR-181, and the Phase 1 study for NKTR-192.
General and administrative expense was $10.9 million in the fourth quarter of 2012 as compared to $11.5 million in the fourth quarter of 2011. G&A expense for the year ended December 31, 2012 was $41.6 million as compared to $46.8 million in 2011.
Non-cash interest expense was $5.4 million and $18.1 million in the fourth quarter and year ended December 31, 2012 , respectively. The company incurred non-cash interest expense as a result of the sale of future royalties related to Cimzia® and Mircera®. No non-cash interest expense was incurred in 2011.
Net loss for the fourth quarter ended December 31, 2012 was $52.9 million or $0.46 loss per share. Net loss for the year ended December 31, 2012 was $171.9 million or $1.50 loss per share. Net loss for the fourth quarter ended December 31, 2011 was $37.5 million or $0.33 loss per share. Net loss for the year ended December 31, 2011 was $134.0 million or $1.19 loss per share.
The company also announced upcoming presentations at the following medical meetings and scientific congresses during the first half of 2013:
33 rd International Symposium on Intensive Care and Emergency Medicine, Brussels, Belgium :
American Association for Cancer Research 2013 Annual Meeting, Washington, DC :
American Academy of Pain Medicine 29 th Annual Meeting, Fort Lauderdale, FL :
American Pain Society 32 nd Annual Scientific Meeting, New Orleans, LA :
Digestive Disease Week 2013, Orlando, FL :
4 th International Congress on Neuropathic Pain, Toronto, Canada :
College on Problems of Drug Dependence 75 th Annual Meeting, San Diego, CA :
Conference Call to Discuss Fourth Quarter and Year-End 2012 Financial Results Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time today, Thursday, February 28, 2013 .
This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investor Relations section of the Nektar website: http://www.nektar.com . The web broadcast of the conference call will be available for replay through Friday, March 15, 2013 .
To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international) Passcode : 98224860 (Nektar Therapeutics is the host)
In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investor Relations page at the Nektar website as soon as practical after the conclusion of the conference call.
About Nektar Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which is being evaluated in Phase 3 clinical studies as a once- daily, oral tablet for the treatment of opioid-induced constipation. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic candidate for chronic pain conditions, is in Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-192, a novel mu-opioid analgesic in development to treat acute pain is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of metastatic breast cancer and is also in Phase 2 studies for the treatment of ovarian and colorectal cancers.
Nektar's technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia. Additional development-stage products that leverage Nektar's proprietary technology platform include Baxter 's BAX 855, a long-acting PEGylated rFVIII program, which is in Phase 3 clinical development.
Nektar is headquartered in San Francisco, California , with additional operations in Huntsville, Alabama and Hyderabad , India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com .
| Nektar Investor Inquiries: | |
| Jennifer Ruddock/Nektar Therapeutics | (415) 482-5585 |
| Susan Noonan/SA Noonan Communications, LLC | (212) 966-3650 |
| Nektar Media Inquiries: | |
| Amanda Connelly/MSL | (404) 870-6865 |
| Mike Huckman /MSL | (646) 500-7631 |
| NEKTAR THERAPEUTICS | ||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
| (In thousands) | ||||||
| (Unaudited) | ||||||
| ASSETS | December 31, 2012 | December 31, 2011 | (1) | |||
| Current assets: | ||||||
| Cash and cash equivalents | $ 25,437 | $ 15,312 | ||||
| Short-term investments | 251,757 | 225,856 | ||||
| Accounts receivable, net | 5,805 | 4,938 | ||||
| Inventory | 18,269 | 12,656 | ||||
| Other current assets | 13,363 | 17,944 | ||||
| Total current assets | 314,631 | 276,706 | ||||
| Long-term investments | - | 173,768 | ||||
| Restricted cash | 25,000 | - | ||||
| Property and equipment, net | 72,215 | 78,576 | ||||
| Goodwill | 76,501 | 76,501 | ||||
| Other assets | 9,443 | 999 | ||||
| Total assets | $ 497,790 | $ 606,550 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ 2,863 | $ 3,019 | ||||
| Accrued compensation | 8,773 | 12,807 | ||||
| Accrued expenses | 8,008 | 6,669 | ||||
| Accrued clinical trial expenses | 17,500 | 11,953 | ||||
| Deferred revenue, current portion | 21,896 | 19,643 | ||||
| Interest payable | 7,083 | 1,805 | ||||
| Convertible subordinated notes | - | 214,955 | ||||
| Other current liabilities | 12,414 | 4,681 | ||||
| Total current liabilities | 78,537 | 275,532 | ||||
| Senior secured notes | 125,000 | - | ||||
| Capital lease obligations, less current portion | 11,607 | 14,582 | ||||
| Liability related to sale of future royalties, less current portion | 128,266 | - | ||||
| Deferred revenue, less current portion | 96,551 | 108,188 | ||||
| Deferred gain | 2,404 | 3,278 | ||||
| Other long-term liabilities | 8,407 | 7,159 | ||||
| Total liabilities | 450,772 | 408,739 | ||||
| Commitments and contingencies | ||||||
| Stockholders' equity: | ||||||
| Preferred stock | - | - | ||||
| Common stock | 11 | 11 | ||||
| Capital in excess of par value | 1,617,744 | 1,597,428 | ||||
| Accumulated other comprehensive loss | (357) | (1,103) | ||||
| Accumulated deficit | (1,570,380) | (1,398,525) | ||||
| Total stockholders' equity | 47,018 | 197,811 | ||||
| Total liabilities and stockholders' equity | $ 497,790 | $ 606,550 |
| NEKTAR THERAPEUTICS | |||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
| (In thousands, except per share information) | |||||||
| (Unaudited) | |||||||
| Three Months Ended | Twelve Months Ended | ||||||
| December 31, | December 31, | ||||||
| 2012 | 2011 | 2012 | 2011 | ||||
| Revenue: | |||||||
| Product sales | $ 10,405 | $ 6,073 | $ 35,399 | $ 24,864 | |||
| Royalty revenues | 908 | 3,095 | 4,874 | 10,327 | |||
| Non-cash royalty revenue related to sale of future royalties | 3,896 | - | 10,791 | - | |||
| License, collaboration and other | 5,937 | 6,614 | 30,127 | 36,289 | |||
| Total revenue | 21,146 | 15,782 | 81,191 | 71,480 | |||
| Operating costs and expenses: | |||||||
| Cost of goods sold | 7,290 | 5,450 | 30,428 | 21,891 | |||
| Research and development | 46,373 | 33,302 | 148,675 | 126,766 | |||
| General and administrative | 10,864 | 11,498 | 41,614 | 46,760 | |||
| Impairment of long-lived assets | - | - | 1,675 | - | |||
| Total operating costs and expenses | 64,527 | 50,250 | 222,392 | 195,417 | |||
| Loss from operations | (43,381) | (34,468) | (141,201) | (123,937) | |||
| Non-operating income (expense): | |||||||
| Interest income | 450 | 661 | 2,315 | 2,244 | |||
| Interest expense | (4,682) | (2,525) | (15,489) | (10,223) | |||
| Non-cash interest expense on liability related to sale of future royalties | (5,416) | - | (18,057) | - | |||
| Other income (expense), net | 70 | (445) | 983 | (1,044) | |||
| Total non-operating expense, net | (9,578) | (2,309) | (30,248) | (9,023) | |||
| Loss before provision for income taxes | (52,959) | (36,777) | (171,449) | (132,960) | |||
| Provision (benefit) for income taxes | (33) | 718 | 406 | 1,018 | |||
| Net loss | $ (52,926) | $ (37,495) | $ (171,855) | $ (133,978) | |||
| Basic and diluted net loss per share | $ (0.46) | $ (0.33) | $ (1.50) | $ (1.19) | |||
| Weighted average shares outstanding used in computing basic and diluted net loss per share | 115,179 | 114,446 | 114,820 | 112,942 |
| NEKTAR THERAPEUTICS | |||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||
| (In thousands) | |||
| (Unaudited) | |||
| Twelve Months Ended December 31, | |||
| 2012 | 2011 | ||
| Cash flows from operating activities: | |||
| Net loss | $ (171,855) | $ (133,978) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||
| Non-cash interest expense on liability related to sale of future royalties | 18,057 | - | |
| Non-cash royalty revenue related to sale of future royalties | (10,791) | - | |
| Stock-based compensation | 16,199 | 18,885 | |
| Depreciation and amortization | 14,508 | 14,951 | |
| Impairment of long-lived assets | 1,675 | - | |
| Other non-cash transactions | 845 | 1,359 | |
| Changes in operating assets and liabilities: | |||
| Accounts receivable | (867) | 20,164 | |
| Inventory | (5,613) | (5,390) | |
| Other assets | 6,031 | (12,267) | |
| Accounts payable | (122) | (3,384) | |
| Accrued compensation | (4,034) | 3,555 | |
| Accrued expenses | 1,495 | 1,013 | |
| Accrued clinical trial expenses | 5,547 | (191) | |
| Deferred revenue | (9,384) | (17,516) | |
| Interest payable | 5,278 | - | |
| Other liabilities | 3,275 | (943) | |
| Net cash used in operating activities | (129,756) | (113,742) | |
| Cash flows from investing activities: | |||
| Purchases of property and equipment | (10,583) | (9,722) | |
| Restricted cash | (25,000) | - | |
| Maturities of investments | 307,887 | 383,052 | |
| Sales of investments | 5,378 | 210,089 | |
| Purchases of investments | (164,662) | (695,371) | |
| Net cash provided by (used in) investing activities | 113,020 | (111,952) | |
| Cash flows from financing activities: | |||
| Proceeds from issuance of senior secured notes, net | 77,940 | - | |
| Repayment of convertible subordinated notes | (172,407) | - | |
| Payment of capital lease obligations | (2,437) | (1,978) | |
| Proceeds from sale of future royalties, net | 119,588 | - | |
| Proceeds from shares issued under equity compensation plans | 4,117 | 4,530 | |
| Issuance of common stock, net | - | 219,783 | |
| Net cash provided by financing activities | 26,801 | 222,335 | |
| Effect of exchange rates on cash and cash equivalents | 60 | 916 | |
| Net increase (decrease) in cash and cash equivalents | 10,125 | (2,443) | |
| Cash and cash equivalents at beginning of period | 15,312 | 17,755 | |
| Cash and cash equivalents at end of period | $ 25,437 | $ 15,312 | |
| Supplemental disclosure of cash flow information: | |||
| Cash paid for interest | $ 9,620 | $ 10,277 | |
| Cash paid for income taxes | $ 1,021 | $ 957 | |
| Supplemental schedule of non-cash investing and financing activities: | |||
| Retirement of convertible subordinated notes in exchange for senior secured notes | $ 42,548 | $ - |
SOURCE Nektar Therapeutics